Best Practices for 510(k) Drafting and Submission: Dos and Don’ts


From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy.

This session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner.

David will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared.

This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas to be Covered:

  • Statute(s) and regulations
  • Definitions
  • Device classification and how to identify predicates: key factors
  • 510(k) program: when the requirement is of 510(K) Regulatory requirements
  • 510(k): requirements, contents and format
  • Substantial equivalence: Special Considerations
  • The task of addressing e-Copy and RTA policy requirements
  • Some of the common mistakes for RTA policy requirements
  • Applicable standards and guidance
  • Common pitfalls and how to prevent them: dos and don’ts
  • What to ensure while preparing for a 510(k) application
  • Response to FDA’s request of additional information
  • Resolving some of the different opinions and interpretations: dos and don’ts
  • Speaker’s practical, actionable and sustainable solutions (PASS)
  • Best Practices to achieve compliance and to stay compliant: dos and don’ts
  • PASS-IT suggestions and recommendations

Who will Benefit:

  • Medical device quality and compliance professionals
  • Pharmaceutical compliance professionals
  • Quality
  • Regulatory affairs
  • CEOs
  • VPs
  • Attorneys
  • Clinical affairs
  • Research & Development
  • Consultants
  • Contractors/subcontractors
  • yone interested in the 510(K) matters

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance